Whole-Body 3D T1-weighted MR Imaging Anatomical Sequences: GE mDixon vs FSE (View) Approaches in Prostate Cancer.

NCT ID: NCT03034070

Last Updated: 2019-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-03-01

Brief Summary

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This study will assess and compare the diagnostic performances and image quality of two WB 3D T1-weighted MR imaging sequences for bone and node staging in patients with prostate cancer : the FSE sequence and a gradient echo (GE) sequence. The latter sequence's main feature is its acquisition time of approximately 1.5 minutes, compared to 18 min for the FSE sequence, reducing the exam's acquisition time, patient discomfort and increasing machine availability.

Detailed Description

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Whole-body (WB) magnetic resonance (MR) imaging has increasingly been used for the screening of bone and soft-tissue metastases in patients with prostate cancer (1). A limitation for its implementation is the 45-60 minutes duration of current WB MRI examinations. Conventional WB MR imaging studies consisted of anatomical two-dimensional (2D) T1-weighted and fat-suppressed fluid-sensitive (proton-density fat-saturated (PDFS) or short-tau inversion-recovery (STIR)) and of a functional diffusion-weighted imaging sequence. Recent research has confirmed the feasibility of replacing the 2D anatomical sequences by a single three-dimensional (3D) T1-weighted fast spin echo (FSE) sequence (2).

This study will assess and compare the diagnostic performances and image quality of two WB 3D T1-weighted MR imaging sequences for bone and node staging in patients with prostate cancer : the FSE sequence and a gradient echo (GE) sequence. The latter sequence's main feature is its acquisition time of approximately 1.5 minutes, compared to 18 min for the FSE sequence, reducing the exam's acquisition time, patient discomfort and increasing machine availability.

The aim of this study is to evaluate the feasibility of the replacement of the WB 3D T1-weighted FSE MR imaging sequence by the WB 3D T1-weighted GE MR imaging sequence.

Conditions

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Prostate Adenocarcinoma Metastasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic performance 3D T1

A 3D T1-weighted GE mDixon MR imaging sequence will be added to the routine 3D T1-weighted FSE sequence. mDixon sub-sequences (Fat and In Phase) are compared to 3D T1-weighted FSE in terms of diagnostic accuracy for M and N staging in prostate cancer patients: Fat, In Phase, Fat+In Phase and the routine 3D T1 will be analyzed separately, blindly and randomly.

Group Type OTHER

Diagnostic performance 3D T1

Intervention Type DIAGNOSTIC_TEST

Although non-invasive, the prospective addition of a new MRI sequence to a routine MRI protocol is considered by our ethical committee as an "interventional" study.

Interventions

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Diagnostic performance 3D T1

Although non-invasive, the prospective addition of a new MRI sequence to a routine MRI protocol is considered by our ethical committee as an "interventional" study.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* prostate cancer with high risk for metastases

Exclusion Criteria

* contraindications to MRI
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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Lecouvet FE, El Mouedden J, Collette L, Coche E, Danse E, Jamar F, Machiels JP, Vande Berg B, Omoumi P, Tombal B. Can whole-body magnetic resonance imaging with diffusion-weighted imaging replace Tc 99m bone scanning and computed tomography for single-step detection of metastases in patients with high-risk prostate cancer? Eur Urol. 2012 Jul;62(1):68-75. doi: 10.1016/j.eururo.2012.02.020. Epub 2012 Feb 17.

Reference Type RESULT
PMID: 22366187 (View on PubMed)

Pasoglou V, Michoux N, Peeters F, Larbi A, Tombal B, Selleslagh T, Omoumi P, Vande Berg BC, Lecouvet FE. Whole-body 3D T1-weighted MR imaging in patients with prostate cancer: feasibility and evaluation in screening for metastatic disease. Radiology. 2015 Apr;275(1):155-66. doi: 10.1148/radiol.14141242. Epub 2014 Dec 15.

Reference Type RESULT
PMID: 25513855 (View on PubMed)

Other Identifiers

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TFE TVE

Identifier Type: -

Identifier Source: org_study_id

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